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Trial record 16 of 62 for:    Baricitinib

A Study of Baricitinib in Healthy Japanese Participants

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ClinicalTrials.gov Identifier: NCT02263911
Recruitment Status : Completed
First Posted : October 13, 2014
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Participants
Intervention Drug: Baricitinib
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Baricitinib Dosing Sequence 1 Baricitinib Dosing Sequence 2 Baricitinib Dosing Sequence 3 Baricitinib Dosing Sequence 4
Hide Arm/Group Description Single oral dose of study drug daily on 5 occasions: Test Treatment 1 (T1) = Baricitinib 2 × 4 milligram (mg) commercial formulation tablets in a fasted state, Reference Treatment 1 (R1) = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, Test Treatment 2 (T2) = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, Reference Treatment 2 (R2) = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and (T2F) = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days. Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days. Single oral dose of study drug daily on 5 occasions: T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days. Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
Period Title: Period 1
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Period Title: Period 1 Washout
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Period Title: Period 2
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Period Title: Period 2 Washout
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Period Title: Period 3
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Period Title: Period 3 Washout
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Period Title: Period 4
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Period Title: Period 4 Washout
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Period Title: Period 5
Started 4 4 4 4
Completed 4 4 4 4
Not Completed 0 0 0 0
Arm/Group Title Overall Study
Hide Arm/Group Description All randomized participants.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
36.8  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
0
   0.0%
Male
16
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
16
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
16
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Japan Number Analyzed 16 participants
16
1.Primary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib
Hide Description [Not Specified]
Time Frame Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Baricitinib T1 Baricitinib R1 Baricitinib T2 Baricitinib R2 Baricitinib T2F
Hide Arm/Group Description:
Baricitinib 2 × 4 mg commercial formulation tablets given orally (PO) once daily (QD) in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
Overall Number of Participants Analyzed 16 16 16 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour/milliliter (ng*h/mL)
626
(19%)
584
(20%)
297
(17%)
301
(17%)
254
(14%)
2.Primary Outcome
Title PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib
Hide Description [Not Specified]
Time Frame Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Baricitinib T1 Baricitinib R1 Baricitinib T2 Baricitinib R2 Baricitinib T2F
Hide Arm/Group Description:
Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
Overall Number of Participants Analyzed 16 16 16 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
622
(19%)
580
(20%)
294
(17%)
298
(17%)
251
(14%)
3.Primary Outcome
Title PK: Maximum Concentration (Cmax) of Baricitinib
Hide Description [Not Specified]
Time Frame Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Baricitinib T1 Baricitinib R1 Baricitinib T2 Baricitinib R2 Baricitinib T2F
Hide Arm/Group Description:
Baricitinib 2 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
Overall Number of Participants Analyzed 16 16 16 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram/milliliter (ng/mL)
107
(29%)
103
(27%)
50.7
(25%)
53.1
(18%)
45.1
(31%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baricitinib T1 Baricitinib R1 Baricitinib T2 Baricitinib R2 Baricitinib T2F
Hide Arm/Group Description Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods. Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods. Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods. Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods. Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
All-Cause Mortality
Baricitinib T1 Baricitinib R1 Baricitinib T2 Baricitinib R2 Baricitinib T2F
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Baricitinib T1 Baricitinib R1 Baricitinib T2 Baricitinib R2 Baricitinib T2F
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baricitinib T1 Baricitinib R1 Baricitinib T2 Baricitinib R2 Baricitinib T2F
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02263911     History of Changes
Other Study ID Numbers: 14612
I4V-MC-JAGO ( Other Identifier: Eli Lilly and Company )
First Submitted: October 8, 2014
First Posted: October 13, 2014
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017